Bradley E Chipps1, Tmirah Haselkorn2, Brandee Paknis3, Benjamin Ortiz3, Eugene R Bleecker4, Farid Kianifard3, Aimee J Foreman5, Stanley J Szefler6, Robert S Zeiger7. 1. Capital Allergy and Respiratory Disease Center, Sacramento, Calif. Electronic address: bchipps@capitalallergy.com. 2. EpiMetrix, Los Altos, Calif. 3. Novartis Pharmaceuticals Corporation, East Hanover, NJ. 4. Center for Genomics & Personalized Medicine, Section of Pulmonary & Critical Care Medicine, Wake Forest University, Winston-Salem, NC. 5. ICON, San Francisco, Calif. 6. The Breathing Institute and Pulmonary Medicine Section, Children's Hospital, Colorado, Aurora, Colo. 7. Department of Allergy, Kaiser Permanente Southern California, San Diego, Calif.
Abstract
BACKGROUND: The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR I) study demonstrated high morbidity in patients with severe or difficult-to-treat asthma despite standard-of-care treatment. OBJECTIVE: We sought to determine the long-term natural history of disease and outcomes in patients in TENOR I after more than a decade. METHODS: TENOR I was a multicenter observational study (2001-2004) of 4756 patients with severe or difficult-to-treat asthma. TENOR II was a follow-up study of TENOR I patients using a single cross-sectional visit in 2013/2014. Overall, the sites participating in TENOR II originally enrolled 1230 patients in TENOR I. Clinical and patient-reported outcomes were assessed, including very poorly controlled asthma based on National Heart, Lung, and Blood Institute guidelines. RESULTS: A total of 341 (27.7%) patients were enrolled in TENOR II and were representative of the TENOR I cohort. The most frequent comorbidities were rhinitis (84.0%), sinusitis (47.8%), and gastroesophageal reflux disease (46.3%). Mean percent predicted prebronchodilator and postbronchodilator FEV1 were 72.7% (SD, 21.4%) and 78.2% (SD, 20.7%), respectively. A total of 231 (72.9%) of 317 patients had positive test responses to 1 or more allergen-specific IgEs. The mean blood eosinophil count was 200/μL (SD, 144/μL). Eighty-eight (25.8%) patients experienced an asthma exacerbation in the prior 3 months requiring hospital attention, oral corticosteroids, or both. More than half (197/339 [58.1%]) had very poorly controlled asthma. Medication use suggested undertreatment. CONCLUSION: TENOR II provides longitudinal data to characterize disease progression, heterogeneity, and severity in patients with severe or difficult-to-treat asthma. Findings show continued morbidity, including a high degree of comorbid conditions, allergic sensitization, exacerbations, and very poorly controlled asthma, including reduced lung function.
BACKGROUND: The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR I) study demonstrated high morbidity in patients with severe or difficult-to-treat asthma despite standard-of-care treatment. OBJECTIVE: We sought to determine the long-term natural history of disease and outcomes in patients in TENOR I after more than a decade. METHODS: TENOR I was a multicenter observational study (2001-2004) of 4756 patients with severe or difficult-to-treat asthma. TENOR II was a follow-up study of TENOR I patients using a single cross-sectional visit in 2013/2014. Overall, the sites participating in TENOR II originally enrolled 1230 patients in TENOR I. Clinical and patient-reported outcomes were assessed, including very poorly controlled asthma based on National Heart, Lung, and Blood Institute guidelines. RESULTS: A total of 341 (27.7%) patients were enrolled in TENOR II and were representative of the TENOR I cohort. The most frequent comorbidities were rhinitis (84.0%), sinusitis (47.8%), and gastroesophageal reflux disease (46.3%). Mean percent predicted prebronchodilator and postbronchodilator FEV1 were 72.7% (SD, 21.4%) and 78.2% (SD, 20.7%), respectively. A total of 231 (72.9%) of 317 patients had positive test responses to 1 or more allergen-specific IgEs. The mean blood eosinophil count was 200/μL (SD, 144/μL). Eighty-eight (25.8%) patients experienced an asthma exacerbation in the prior 3 months requiring hospital attention, oral corticosteroids, or both. More than half (197/339 [58.1%]) had very poorly controlled asthma. Medication use suggested undertreatment. CONCLUSION: TENOR II provides longitudinal data to characterize disease progression, heterogeneity, and severity in patients with severe or difficult-to-treat asthma. Findings show continued morbidity, including a high degree of comorbid conditions, allergic sensitization, exacerbations, and very poorly controlled asthma, including reduced lung function.
Keywords:
Asthma; control; difficult-to-treat; exacerbations; follow-up; long-term; observational study; severe; the Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens
Authors: Christopher S Ambrose; Bradley E Chipps; Wendy C Moore; Weily Soong; Jennifer Trevor; Dennis K Ledford; Warner W Carr; Njira Lugogo; Frank Trudo; Trung N Tran; Reynold A Panettieri Journal: Pragmat Obs Res Date: 2020-07-16
Authors: Sigfus Gunnlaugsson; Kimberly F Greco; Carter R Petty; Gabriella C Sierra; Natalie P Stamatiadis; Christine Thayer; Adam G Hammond; Lauren M Giancola; Umakanth Katwa; Tregony Simoneau; Sachin N Baxi; Jonathan M Gaffin Journal: J Asthma Date: 2021-03-23
Authors: Stephen Vesper; Larry Wymer; John Kroner; Jacqueline A Pongracic; Edward M Zoratti; Frédéric F Little; Robert A Wood; Carolyn M Kercsmar; Rebecca S Gruchalla; Michelle A Gill; Meyer Kattan; Stephen J Teach; Shilpa Patel; Christine C Johnson; Leonard B Bacharier; James E Gern; Daniel J Jackson; Steven M Sigelman; Alkis Togias; Andrew H Liu; William W Busse; Gurjit K Khurana Hershey Journal: J Allergy Clin Immunol Date: 2021-10-02 Impact factor: 14.290
Authors: Weily Soong; Bradley E Chipps; Sean O'Quinn; Jennifer Trevor; Warner W Carr; Laura Belton; Frank Trudo; Christopher S Ambrose Journal: J Asthma Allergy Date: 2021-06-25